Wednesday, April 24, 2024

Pfizer ‘Chose Not to’ Tell Regulators About SV40 Sequence In Covid Shots

A senior Health Canada official says pharma giant Pfizer made a conscious decision to not advise regulators that its mRNA COVID-19 vaccine contained a DNA sequence from the Simian Virus 40 (SV40).

This information appears among multiple emails between staff from key drug regulators, including Health Canada (HC), the U.S. Food and Drugs Administration (FDA), and the European Medicines Agency (EMA). The information was obtained through an access-to-information request.

On Aug. 23, 2023, Dr. Dean Smith, a senior scientific evaluator in HC’s Vaccine Quality Division, wrote an email to a colleague at the FDA about SV40.
Health Canada had obtained confirmation two weeks earlier from Pfizer that SV40 DNA sequences were present in its COVID-19 vaccine.
“I understand that there have been internal discussions at CBER [Center for Biologics Evaluation and Research] regarding the presents [sic] of an SV40 enhancer/promoter sequence, noting that its presence is unrelated to the purpose of the Pfizer’s plasmid as a transcription template for their mRNA COVID-19 vaccine,” wrote Dr. Smith.

“Pfizer has communicated to us recently, that they apparently chose not to mention this information to EMA, FDA or HC at the time of their initial or subsequent submissions.”

Dr. Smith added the information had been independently made public in April 2023, via a pre-print study from U.S. scientist Kevin McKernan.

Mr. McKernan, a genomics expert, had found quantities of DNA in the mRNA shots above the regulatory threshold set out by the health agencies. Dr. Smith wrote that the study had resulted in “questions coming to agencies.”

The Epoch Times had contacted HC on the matter on July 17. The first email related to SV40 within Health Canada released in the access-to-information package was sent two days later, on July 19.

In that email, Dr. Tong Wu of HC’s Vaccine Quality Division reached out to his colleague Dr. Michael Wall, a senior biologist evaluator.

“Co [Pham, executive director of HC’s Centre for Vaccines, Clinical Trials and Biostatistics] agreed to have an IAS for the SV40 promoter sequence as we discussed today. We can talk about it tomorrow,” Dr. Wu wrote. “IAS” could be a reference to an Issue Analysis Summary to evaluate a new regulatory affair.

As first reported by The Epoch Times in October, Health Canada was not aware of the SV40 enhancer presence. Since then, the FDA and the EMA have both confirmed they also weren’t aware of its presence.

Health Canada has since maintained that the SV40 enhancer/promoter sequence is a “residual DNA fragment” in Pfizer-BioNTech COVID-19 vaccine. “The fragment is inactive, has no functional role, and was measured to be consistently below the limit required by Health Canada and other international regulators,” the agency has repeatedly said.

‘ZERO Checks’

This view has been challenged by Mr. McKernan and others, including Dr. Philip Buckhaults, professor of cancer genomics and director of the Cancer Genetics Lab at the University of South Carolina.

In response to the information released by Health Canada, Mr. McKernan posted a thread on the X platform. “No prior vaccine in Canada has been approved with such a sequence contaminant,” he said.

“Pfizer assured [HC] the sequence is not material to plasmid manufacturing,” he added. “This is an overt lie. You cannot make plasmids without the promoter for the antibiotic resistance gene. It is active in mammalian cells. If it’s not needed, why is it in there?”

Mr. McKernan also noted how HC has asked Pfizer for its Polymerase Chain Reaction (PRC) protocol, saying this means “they have performed ZERO checks on this DNA contamination themselves and are entirely relying on the word of the manufacturer.”

A response to a Canadian Member of Parliament’s question tabled in the House of Commons by Health Canada appears to be line with this observation. “It is important to assess the results using the authorized validated assays performed by the vaccine manufacturers to ensure that the quality of commercial vaccine lots are comparable to lots shown to be safe and efficacious in clinical studies,” said Health Canada in December.

Concerns related to the presence of unintended DNA in the mRNA shots pertain to their potential to integrate into the human genome and cause issues like cancer. The Florida State Surgeon General Dr. Joseph A. Ladapo has called for a halt of mRNA shots over these risks.

Health Canada said in March in a document tabled in Parliament that “any claims that the presence of the SV40 promoter enhancer sequence is linked to an increased risk of cancer are unfounded.”

Dr. Buckhaults has started a scientific study to ascertain those integration risks. On April 23, he wrote on X that he had confirmed previous findings that the amount of DNA in mRNA shots exceeds the limit set by regulators.

“Yes, there was more than 10 ng/dose. I am sure of it now,” he wrote while posting his methodology. This is the same threshold applied by Health Canada.

Even if the amount of DNA was below, there are still concerns the threshold was set for regular vaccines and not the new technology using lipid nano particles (LNP).

Dr. Buckhaults wrote that the “10 ng limit is not appropriate for LNP encapsulated DNA,” adding that “as far as I know there have been no safety studies for this situation. It was not possible because of the abbreviated timeline during the emergency you saw authorization.”

Seeking ‘Remedy’

In his August 23 email to the FDA employee, Dr. Smith said HC Canada did not view the SV40 issues as an “urgent risk topic.” However, the official responsible for evaluating the safety of vaccines expressed concerns about how news of the SV40 could impact the upcoming fall 2023 vaccination campaign.
“It would be unfortunate if the information circulating had a negatively [sic] impact on public acceptance of the vaccine this year or in the future,” he said.

Despite being of this view, Dr. Smith said regulating agencies should work to encourage Pfizer to “remedy the situation” before the campaign.

In the email, Dr. Smith said HC believed the upcoming rollout of the fall COVID-19 vaccine campaign meant the agencies should be “on the same page.”

Mr. Smith’s email was written a day after Pfizer provided a response to a Quality Clarifax submitted by HC around the SV40 promoter. If deficiencies are identified in Clinical Trial Applications, HC may request additional information, which is known as a Clarifax.

On August 29, HC senior biologist Dr. Wall wrote an email to senior evaluator Dr. Tong Wu, where he said he and Mr. Smith agreed they should not inform Pfizer of their interaction with the EMA and U.S. FDA on the SV40 promoter, “especially they [sic] do not seem to care much at this moment.”

“However, we can not say nothing! Please see the following text that Julie and I worked out,” Mr. Wall added, before providing a draft comment to Pfizer’s response that was blacked out.

The same day, Dr. Wall also sent an email to Dr. Wu with a draft of the Clarifax questions to be sent to Pfizer, which included the statement, “Health Canada would continue to work with international regulatory partners to achieve harmonisation regarding removal of these sequence elements from the plasmid for future strain changes.”

Pfizer did not respond to a request for comment from The Epoch Times

Commenting on DNA contamination, Health Canada reiterated its previous position on the matter.

“Based on its evaluation of the data and scientific information for the vaccine, Health Canada has concluded that the risk/benefit profile continues to support the use of the Pfizer-BioNTech vaccine,” said spokesperson Anna Maddison.

Dr. David Speicher, a Canadian virologist who replicated the findings from Mr. McKernan and Dr. Buckhaults with Canadian mRNA vials, told The Epoch Times he’s preoccupied about what’s been revealed in the internal Health Canada emails. He notes that while Health Canada has dismissed the DNA fragments as biologically inactive with no functional role, they judged worthy to hold discussions with other regulators.

“We know from testing several vials that the level of SV40 enhancer-promoter in the XBB.1.5 booster is at similar levels as the others Pfizer COVID modRNA vaccines, making it just as problematic,” he says. “Pfizer has not cleaned up the vaccine, yet the regulators are sadly more concerned about vaccine uptake in the population rather than the health risks from these vaccines.”




Tuesday, April 23, 2024

COVID-19 Vaccine Protection Among Children Plummets Within Months: CDC Study

Children who received an original COVID-19 vaccine have little protection against hospitalization just months after vaccination, according to a new study from the U.S. Centers for Disease Control and Prevention (CDC).

Children initially have 52 percent protection against hospitalization but that estimated effectiveness plummeted to 19 percent after four months, according to the paper.

Protection against so-called critical illness also dropped sharply, from 57 percent to 25 percent, researchers found.

The researchers include CDC employees and the paper was published in the CDC’s weekly digest on April 18.
The study covered children who received two or more doses of the original Pfizer-BioNTech or Moderna COVID-19 vaccines from Dec. 19, 2021, through Oct. 29, 2023.

The study involved children aged 5 to 18 who were hospitalized with acute COVID-19 and tested positive for the illness and compared them to a control group of children hospitalized with COVID-19-like symptoms but who tested negative for COVID-19.

Researchers drew data from the Overcoming COVID-19 Network, which includes health care sites in most of the United States, and ended up with 1,551 case patients and 1,797 in the control group.

The study found that “receipt of ≥2 original monovalent COVID-19 vaccine doses was associated with fewer COVID-19–related hospitalizations in children and adolescents aged 5–18 years; however, protection from original vaccines was not sustained over time,” Laura Zambrano, a CDC epidemiologist, and her co-authors wrote.

It also recorded a similar drop in protection against critical illness, defined as being placed on mechanical ventilation, vasoactive infusions, extracorporeal membrane oxygenation, or dying.

The researchers asserted that the results highlighted the current CDC guidance that all people aged 6 months and older receive one of the newest COVID-19 vaccines, which were introduced in the fall of 2023 with clinical data from just 50 humans and no efficacy estimates. The CDC only publishes papers in its weekly digest, the Morbidity and Mortality Weekly Report, after they’re shaped to “comport with CDC policy.” The papers are not peer-reviewed.

Ms. Zambrano did not respond when asked for data suggesting that the currently available shots provide longer-lasting protection than the original vaccines.

The CDC’s website says, in promoting vaccination, that COVID-19 vaccines are “effective at protecting people from getting seriously ill, being hospitalized, and dying” but the hyperlink that ostensibly supports the statement goes to a page that is not live.

U.S. authorities have been moving COVID-19 vaccines to a once-a-year model, similar to influenza vaccines. The model features updating the formulation of the vaccines on an annual basis, in an acknowledgment that any protection the vaccines give quickly wanes. The formulation is typically updated in the fall.

Just 14 percent of children, and 23 percent of adults, have received one of the newest vaccines as of April 6, according to CDC estimates. The available vaccines are messenger RNA (mRNA) shots from Pfizer and Moderna and an alternative from Novavax.

Dr. Jane Orient, executive director of the Association of American Physicians and Surgeons, noted that, according to the new paper, the maximum effectiveness estimates against hospitalization were 61 percent, regardless of how the data were sliced, that more deaths were recorded among the case patients, and the median hospitalization duration was four days for both groups.

“I do not see how a clinician whose concern is treating patients and whose job does not depend on pushing mRNA vaccines would find this a basis for recommending shots—quite the contrary,” Dr. Orient, who was not involved in the research, told The Epoch Times in an email. “It reeks of conflict of interest.”

Stated limitations of the paper include not assessing post-infection immunity and a lack of sequencing data.

The conflict of interest section runs 688 words and includes some of the authors reporting funding from Pfizer and Moderna or ownership of Pfizer stock.


UC Riverside Breakthrough: Novel Live-Attenuated RNA Virus Vaccine Eliminates Chasing Strains?

According to a recent University of California, Riverside (UCR) media release, scientists at the Inland Empire-based Southern California research center recently demonstrated a novel RNA-based vaccine strategy that is effective against any strain of a virus and can be used safely even by babies or the immunocompromised.

This would be a monumental breakthrough, one that would eliminate the current “chasing of strains” involved with the flu and now COVID-19 shots. Specifically, the team led by Rong Haia Ph.D. and Shou- Wei Ding, Ph.D. characterized a unique live-attenuated RNA virus vaccine, where attenuation resulted from the elimination of the viral RNAi suppressor and enhanced the production of virus- targeting small- interfering RNAs.

The UCR team demonstrates that single-dose immunization with the vaccine just 2 days in advance induced full protection in neonatal and adult mutant mice lacking adaptive immunity. Also, the immunized mutant mice remained protected against lethal challenge for at least 90 days postvaccination.

Human enterovirus- A71, influenza A, and dengue viruses all encode a similar RNAi suppressor, suggesting potential for developing a distinct type of virus vaccine to confer rapid and effective protection in infants and other immune- compromised individuals.

TrialSite this week purchased the study, reviewing below in conjunction with the UCR News media entry.

The Problem

Researchers on an annual basis make attempts to predict the four influenza strains that are most likely to be prevalent during the upcoming flu season. And every year, people line up to get their updated vaccine, hoping the researchers formulated the shot correctly.

Ditto for COVID vaccines: these vaccine products are reformulated to target sub-variants of the most prevalent strains circulating in the U.S.

What’s the Breakthrough?

Based on a recent breakthrough published earlier in the week in Proceedings of the National Academy of Sciences (PNAS), the new strategy would eliminate the need to create all these different shots, because it targets a part of the viral genome that is common to all strains of a virus.

“What I want to emphasize about this vaccine strategy is that it is broad,” said UCR virologist and paper author Rong Hai. “It is broadly applicable to any number of viruses, broadly effective against any variant of a virus, and safe for a broad spectrum of people. This could be the universal vaccine that we have been looking for.”

The Novel Vaccine

With traditional vaccines contain either a dead or modified, live version of a particular virus, with these products the body’s immune system recognizes a protein in the virus and mounts an immune response. Eliciting T-cells to attack the virus, thereby inhibiting the spread of the pathogen. It also produces “memory” B-cells that train your immune system to protect you from future attacks.

Interestingly enough, this novel vaccine discovered at UCR uses not mRNA, but actually also a live, modified version of a virus. The difference, however, from others; this novel candidate does not rely on the vaccinated body having this traditional immune response or immune active proteins — which is the reason it can be used by babies whose immune systems are underdeveloped, or people suffering from a disease that overtaxes their immune system. Rather, the experimental vaccine relies on small, silencing RNA molecules.

According to Shouwei Ding, distinguished professor of microbiology at UCR, and lead paper author “A host—person, a mouse, anyone infected— will produce small interfering RNAs as an immune response to viral infection. These RNAi then knock down the virus.”

Jules Bernstein reported on this finding for UCR News, educating that viruses typically generate RNAi response blockers in the form of proteins. According to Ding, “If we make a mutant virus that cannot produce the protein to suppress our RNAi, we can weaken the virus. It can replicate to some level, but then loses the battle to the host RNAi response.” Elaborating on this concept, Ding shared with the UCR reporter, “A virus weakened in this way can be used as a vaccine for boosting our RNAi immune system.”

Validating in Early-Stage Study

When the researchers tested this strategy with a mouse virus called Nodamura, they did it with mutant mice lacking T and B cells. With one vaccine injection, they found the mice were protected from a lethal dose of the unmodified virus for at least 90 days. Note that some studies show nine mouse days are roughly equivalent to one human year.

There are few vaccines suitable for use in babies younger than six months old. However, even newborn mice produce small RNAi molecules, which is why the vaccine protected them as well. UC Riverside has now been issued a US patent on this RNAi vaccine technology.

In 2013, the same research team published a paper showing that flu infections also induce us to produce RNAi molecules. “That’s why our next step is to use this same concept to generate a flu vaccine, so infants can be protected. If we are successful, they’ll no longer have to depend on their mothers’ antibodies,” Ding said.

Their flu vaccine will also likely be delivered in the form of a spray, as many people have an aversion to needles. “Respiratory infections move through the nose, so a spray might be an easier delivery system,” Hai said.

Additionally, the researchers say there is little chance of a virus mutating to avoid this vaccination strategy. “Viruses may mutate in regions not targeted by traditional vaccines. However, we are targeting their whole genome with thousands of small RNAs. They cannot escape this,” Hai said.

Ultimately, the researchers believe they can ‘cut and paste’ this strategy to make a one-and-done vaccine for any number of viruses.

“There are several well-known human pathogens; dengue, SARS, COVID. They all have similar viral functions,” Ding said. “This should be applicable to these viruses in an easy transfer of knowledge.”




Monday, April 22, 2024

Fighting an invisible illness: the curse of Long Covid

Note that she fell ill AFTER being vaccinated


The first time I got Covid it landed me in hospital on Christmas Day. It was 2022 and my husband dropped me off outside Emergency, our two worried kids watching from the car. I didn’t want to leave them but I had no choice: I’d been ­experiencing wave after wave of horrible nausea, and I had never felt my heart beat so fast. I felt on the verge of collapse. Being Covid positive, I was told by hospital staff to wait on a bench outside and that’s where I sat, miserably, until a nurse came to see me.

“So you have Covid,” she said. “Well, what did you come here for? Do you think I have a magic pill that’s going to make you feel better?” The rational, fact-finding journalist part of my brain knew what she said was correct – there wasn’t a quick fix, and being Christmas the ­hospital was operating with skeleton staff who were overworked and exhausted at this point in the pandemic. But I had never felt so sick in my life, and I simply did not know what else to do. Surely there was someone who could help me?

What I didn’t realise in that moment was that, 16 months later, I would still be struggling with this same feeling of utter desperation, hopelessness and fear. Because since the acute phase of the infection ended, I have been ­struggling with the mysterious and debilitating condition known as Long Covid.

I am not alone: it is estimated that one in 10 people who contract Covid develop Long Covid, which is defined in Australia as being symptomatic three months after the original infection. According to research publishedlast year, as many as 65 million people have Long Covid worldwide, with numbers ­increasing with each new wave of the viral ­infection. In Australia, there is no national registry keeping tabs on the number of cases but a recent federal parliamentary inquiry into Long Covid heard there could be anywhere between 200,000 and two million sufferers.

What is clear from data collected globally since the pandemic began is that Long Covid affects more women than men, especially women in their thirties and forties. (Being a 45-year-old woman, I am a fairly typical case.) As a patient, and as a journalist, I wanted to understand why Long Covid remains largely a mystery, even though scientists and physicians have had more than four years to get to grips with it. The first key question, for me: why are women getting Long Covid more than men?

“I wish I could tell you but we just don’t know yet,” says Professor Steven Faux, who ­co-founded one of the first Long Covid clinics in Australia, at St Vincent’s Hospital in Sydney. “There are a handful of reasons [being explored]. One is psychosocial, that we put women in harm’s way when it comes to caring for people because most nurses are women. “

There is another issue, he says. “A group of researchers in the US said, ‘We think it is happening in that period because they’re perimenopausal and no one is looking at that. Is that possible?’”

But, Faux says, the most fascinating theory is US immunologist Professor Akiko Iwasaki’s research around the hormonal response – that the female’s immune system is more aggressive than the male’s, and turns on faster and stronger to protect any potential unborn child. But it then exhausts itself and it can’t keep fighting against the virus and stop it from developing reservoirs in different organs.

Faux sees more women than men at St Vincent’s Long Covid clinic (55 per cent female patients compared with 45 per cent male). The most common age group is 31-45 years, followed by 46-60 years. This echoes the experience of other clinics in Australia and overseas and was also noted as a concern by the parliamentary committee inquiry into Long Covid. “There’s just a lot more women,” Faux says.

The reason I am talking to Faux in his tiny ­office at St Vincent’s between clinic appointments on a Thursday afternoon is not only ­because is he one of the leading Long Covid experts in Australia and I selfishly want to pick his brain, but because he is the first person in this country to have written a comprehensive guide to the illness. To be published in May, Long Covid: Expert Advice, from Diagnosis to Treatment and Recovery is aimed at patients, people just like me, who have been struggling to get better. It also advocates for us. And it does so in a particularly empathetic way.

“If you are living with Long Covid, we know that in your own ways you try to keep going, try to be the person you were, while battling the fear that you will never be the same,” Faux writes early on, setting the tone. “This book is an attempt to say to all of you: we see you.”

Those few sentences in the book encapsulate my experiences in a way that no other doctor has been able to. It’s comforting to simply read Faux’s acknowledgment of the awful symptoms – the erratic heartbeat, the exhaustion, the brain fog, the doctors’ ­appointments, the specialists’ appointments, juggling work, juggling children and the heavy weight of waking up every morning and not feeling any better.

“One of the things about Long Covid is that it’s a largely invisible illness,” Faux writes. “When you have it, you don’t necessarily look any different. It is not like you’ve lost a limb or have a cast on your harm. Fatigue or cognitive impairment is often subjective; it’s hard to show people you are fatigued because the only way to do that is to complain about the symptom.”

Faux is the Director of Pain Medicine at St Vincent’s, and previously spent 22 years as the director of rehabilitation. He has spent almost 30 years helping people ­recover from injury and illness. He and his ­colleagues recognised early on in the ­pandemic that there was a need to plan beyond the acute infection stage. And after working on the front line in the Covid wards for months, he saw first-hand what was coming. “What I knew of previous pandemics, and the effects of viral illnesses such as HIV and polio, was that the pandemic was about to ­deliver thousands of people who would be ­damaged by this infection and who would ­require rehabilitation,” he writes.

His unit soon started getting referrals for Covid patients who still had symptoms after three months. They called themselves “long haulers” on social media and were reporting breathlessness, coughing and exhaustion.

“We initially thought it was because the virus was destroying their lungs and they needed pulmonary rehab – but then a lot of the people we were ­seeing couldn’t go back to work because they couldn’t concentrate,” Faux tells me.

“I had colleagues emailing me saying, ‘Are you using brain injury rehab for these people?’ and it was then I ­realised that if we didn’t do something proactively, we were going to end up with an army of people who were disabled for some time.”

More than 200 different symptoms are now ascribed to Long Covid. According to a 2021 review quoted by Faux in his book, the most common is fatigue (45.1 per cent), followed by breathlessness, then insomnia, difficulty waking, anxiety, depression, brain fog, muscle pain, palpitations, headaches and a loss of taste and smell. But it can be hard to pin down. “People with Long Covid often say they don’t feel themselves, or are unable to get on with things as they used to, but many can’t really articulate what they feel,” he writes. “At the St Vincent’s clinic I’ve seen people lose their jobs as a result of Long Covid. I’ve seen it place stress on relationships and cause untold anxiety.”

Faux estimates there could be as many as one million Australians living with Long Covid, given that around one in ten people who get Covid develop Long Covid and more than 11 million Australians are thought to have contracted Covid since the pandemic began. “This figure would place Long Covid high on the list of the most significant medical conditions ­affecting the Australian population,” he points out. “Compare this with type 2 diabetes at 1.3 million, asthma at 2.7 million, heart disease or stroke at 1.2 million and cancer at 1 million.”

I managed to avoid Covid for the first two years of the pandemic, and I was beginning to think I was one of the lucky ones until I finally tested positive. This, of course, was well after the peak of the pandemic, after lockdowns, and after almost every Australian had been vaccinated. By then, we had certainly heard of Long Covid. The Weekend Australian Magazine had reported on the condition back in 2020 – a growing army of Covid “long-haulers”, many of whom had only a mild case of Covid-19, ­describing “a medley of lasting symptoms”.

When I fell ill, three days after my son tested positive in December 2022, I wasn’t too worried. I was fully vaccinated. The symptoms were ­initially mild: I had a temperature for a few days, a slight cough and felt generally unwell. But the symptoms dramatically escalated one evening when I was cooking dinner for my ­family. A wave of nausea and dizziness hit, my heart started beating fast and erratically and I thought I was going to faint. I immediately stopped what I was doing and lay down on the couch, waiting for it to pass. It didn’t.

During my first hospital visit on Christmas Day, they checked my heart and found nothing wrong, then hooked me up to a bag of IV fluids. I overheard the doctor ask a nurse whether I was eligible for antiviral drugs. “No, she’s too young,” came the reply. I was discharged a few hours later as there was nothing more they could do. I was back in hospital on New Year’s Eve with the same frightening symptoms. This time I underwent exhaustive tests and spent a night in the Covid ward before being discharged. Two weeks later, I finally tested negative to Covid – though my symptoms remained.

“They will lift,” a close friend reassuringly messaged me. But even as time went by, there was no easing of the symptoms. The godawful nausea meant I had no appetite and lost five kilos, and I couldn’t do anything physical without feeling dizzy. My husband had to take care of me and keep the kids occupied during a month of school holidays. Worst of all, my heart was behaving very strangely. All of a ­sudden I would feel it beating as if it would leap out of my chest, then I would get this horrible jittery feeling like when you’ve had too much coffee. Sometimes this would last for days.

I attempted to go back to my job as a journalist for The Australian’s WISH magazine in the middle of January 2023. I was working from my parents’ house – they were helping look after my children. One day I’d been working for about two hours when another wave of nausea and dizziness hit. I remember crying in despair in front of my husband and kids, frightened that this illness would rob me of my career.

Then came the dreaded “brain fog” reported by many Long Covid sufferers: I kept forgetting words and confusing things. The words and memories were there, I just couldn’t access them. It took away my confidence to write – a key part of my job – as well as my ability to function day-to-day as a mother and wife with school-age children.

Many studies have found that Long Covid affects the brain, and it’s a key part of the rehabilitation program at the St Vincent’s clinic – even though Faux admits the medical profession is at a loss to explain what causes the fog. “It’s unclear whether the effects on the brain are due to the persistence of the virus or to the immune system’s response, but brain ­imaging studies have shown that the parts of the brain involved include the orbitofrontal areas (above the eyes) close to where the olfactory (smelling) nerves enter the brain, and near some of the areas of the memory centres (the hippocampus and limbic systems),” he writes. “There is also evidence of thinning of the brain’s grey matter in those with Long Covid who have brain fog.”

The other debilitating symptom Faux sees that has also changed my life is post-exercise malaise. It means you can’t tolerate any type of exercise, and your body tells you afterwards – not during – with a swift return of symptoms. We’re not talking about the ­serious exertion of running or ­lifting weights in the gym; it can be triggered by the expending of ­energy in almost any way. Carrying too many groceries one evening meant I woke up the next day to find my nausea had returned powerfully, and I found getting out of bed incredibly difficult. The day before, I’d felt fine.

As I grew to understand, people living with Long Covid don’t have a linear recovery. You can have a good day, or even have a good week – and then you can overdo it physically, without realising, and be back to square one. For me, this was when the fear crept in and I found ­myself panicking that I might never recover.

“Living with uncertainty is one of the big ­issues for Long Covid,” explains Faux. “We ­always advise people with Long Covid a bit like we approach cancer rehabilitation – if you’re having a good day, enjoy it and don’t expect it to be the same tomorrow. And if you are having a shit day, then ride it out and maybe tomorrow will be completely different.”

While I was undergoing a series of tests last year to find out why my heart was beating erratically, a doctor helpfully told me that Long Covid is a post-viral syndrome much like Myalgic Encephalomyelitis/Chronic Fatigue Syndrome, and the sheer volume of cases mean the symptoms cannot be dismissed as psychosomatic. “One of the things that people were initially saying with Long Covid is that these people are histrionic, they are putting it on,” Faux says. “But it became clear to me when we opened the clinic and talked to the first patients that they were not.

“The patients we see can’t work and they want to work. They need money and they have to put bread on the table. They don’t have a ­history of chronic pain or diagnosable illnesses. These are people with very little to gain by being sick.”

There is a six- to nine-month waiting list to get into the St Vincent’s Long Covid clinic. Faux and Associate Professor Anthony Byrne, a respiratory physician, set up the team that includes nurses, physiotherapists, a sleep specialist, a neurological rehabilitation expert and a psychologist. Each patient who is referred by their GP gets an assessment and a tailored rehabilitation program. It’s a slow process, but it does work. “If patients are identified early and they get a psychologist and a physio, or a physio and ­occupational therapist, whatever they need, and they start treatment early, the evidence from overseas is that they recover faster,” ­explains Faux. “And the evidence from our ­clinic is that there is a substantial return to work at six months following the commencement of rehabilitation.”

Last April, a federal parliamentary committee made nine recommendations following its inquiry into Long Covid. Among them was that the government should partner with state health departments to develop and fund more multidisciplinary Long Covid clinics. Yet when Health Minister Mark Butler released the federal government’s response to the inquiry, this was not one of the recommendations it supported. In the same month, the government committed $50 million of funding for research into Long Covid and established a national database on the disease. In fact, despite the demand for Long Covid clinics and the committee’s recommendations, governments appears to be withdrawing their support for them. In an RMIT study published last October co-lead author Dr Shiqi Luo stated: “We have insufficient Long Covid clinics to meet the demand”. An ABC investigation last December found five of the country’s 23 clinics have either been scaled back or closed.

Unlike me, Julie Lamrock contracted Covid early in the pandemic, in 2019, when a passenger she collected in her shuttle bus from the Overseas Passenger Terminal disembarked from the Ruby Princess cruise ship.When The Weekend Australian Magazine reported on Covid “long-haulers” in 2020, Julie was still ­experiencing pain, fatigue and brain fog. Her symptoms have never abated. Today, she ­describes her now four-year battle with Long Covid as a “living nightmare”. “Only last year did I start to go out again,” she says. “but the pain is always there. The fatigue is always there. I actually go to sleep in pain and I wake up in pain … and I’m living this every day.”

She says her treatment includes visits to a pain specialist and a pain psychiatrist, but after Nepean Hospital ceased its Covid-19 follow-up service she was no longer being treated as any part of a cohesive Long Covid treatment plan. “There’s nothing happening. Why haven’t I been told to go and see a [particular specialist] doctor? Why isn’t there a system where every doctor can turn around and say, ‘Well, here’s a number you can call and yes, here’s a referral to this clinic, get this done, get that done’?”

I was referred to a Long Covid clinic by my cardiologist last April. I received a call in June asking me what I needed help with; I told them. I didn’t hear anything back until October last year when I received another call saying the clinic was moving online and Long Covid case management was going back to GPs. I have since learned that what was once my Long Covid clinic is now an eight-week online education program and a support group.

When, in writing this article, I asked Health Minister Mark Butler about the future of Long Covid clinics, he did not directly respond, noting only the need for “multidisciplinary team-based healthcare for people with chronic and complex conditions like Long Covid.” The Department of Health and Aged Care released a plan in February this year addressing Long Covid, now referred to in government circles as PASC (Post-Acute Sequelae of COVID-19). There is no mention of Long Covid clinics. “States and territories decide the mix of the ­services and functions delivered in their jurisdiction … some have used funding to establish clinics for the management of people with PASC,” the plan states. “People with PASC will be able to benefit from the Government’s … commitment” to “expand general practices”.

Faux thinks this approach is flawed, and Long Covid patient care should be done in multidisciplinary rehab clinics because it’s not easy to treat. “The GPs are doing their best, but there’s not enough GPs and it’s very complicated because you’ve got to rule out everything else first,” he says.

People are not going to stop getting Covid and, in turn, Long Covid. “In January of this year, 100,000 positive cases were registered in the country. 100,000 people got Covid. That means about 10,000 people got Long Covid,” Faux tells me. “And every month there’ll be another 10,000. There’s lower vigilance with respect to Covid vaccinations and so we expect that people will get it a little bit more. There’s been no decrease in demand at the clinic.”

Faux quotes research in his book that shows 91 per cent of Long Covid sufferers have improvement in symptoms within 12 months; I was also told this by my cardiologist, who urged me just to hang on, as it was most likely I would get better within a year. And I did. I remember cycling with my family to a pool in February this year and feeling totally fine – fit, even. I had also gone back to reformer pilates. “Finally, I’m properly myself again,” I said to my husband.

But three days later, I tested positive for Covid. This time I was prepared.

After multiple conversations with my kind GP, I found out that even with Long Covid I wasn’t eligible for the antiviral drug Paxlovid as I was too young and was not severely immunocompromised. But I could get a course of antivirals privately for $1200.

It was an extraordinary amount of money, but I was willing to pay it in order to avoid a repeat of what I’d been through before. I dispatched my husband to get the antivirals that night; within two days I’d tested negative to Covid and my symptoms were ­almost gone. I was due to finish the five-day ­antiviral course on a Sunday, and I was already planning to go back to work on the Monday. But as soon as I finished the antivirals, my Long Covid symptoms came back: the crippling ­nausea, the irregular heartbeat, the exhaustion. I started to panic. How could I be back here again?

Five weeks later, I’m sitting in Faux’s ­office. “The statistics say you will get better,” he ­kindly reassures me. I tell him how I’m still struggling with nausea, fatigue and post-exercise malaise. I’ve stopped all exercise and I am back mostly working from home. “It’s going to be slow, and that will be very frustrating – but you have to try and look after ­yourself in that time,” he says. The empathy and understanding he shows me during our hour-long interview is also apparent in every single chapter in his book. Faux not only truly sees me and all people living with Long Covid, he has compiled a comprehensive management plan to help. “Your road to recovery may be a long one, unfortunately, but you are not alone and you are already one step ­closer to your destination,” he writes.

As for the future, Faux is full of hope. He says there is a lot of research being done around the world on the condition, from examination of its causes to trials of drugs to treat it. “It is already better now than it was a year ago, and we’re optimistic that this trajectory will continue,” he notes. “The more we know, the better the outcomes for people with Long Covid will be.”




Sunday, April 21, 2024

Japanese Real-World Observational Study: mRNA Vaccines how Low efectiveness

From February 1 to March 17, 2022, Epidemiological, public health and health economic researchers representing Hiroshima University in Japan along with Japan’s Ministry of Health, Labor and Welfare, Health Insurance Bureau, Medical Economics Division conducted a test-negative case-control study using a dataset of 117,335 individuals, collected through the COVID-19 J-SPEED form in the PCR center at Hiroshima Prefecture, Japan.

The study team, represented by corresponding author Yui Yumiya, Ph.D., MPH, Assistant Professor in the Graduate School of Biomedical and Health Sciences (Medical), estimated a propensity score matching for vaccine status based on participants’ demographic characteristics. Thereafter, the team calculated the odds ratio from logistic regression to determine any association between COVID-19 vaccination status and test positivity rate adjusting for symptoms, exposure to close contact, as well as previous history.

The Hiroshima University-led team of researchers established vaccine effectiveness as a formula (1 –aORs) ×100%). The team concluded that the data generated points to the protective effect of the COVID-19 vaccines against the Omicron strain. However, that’s interpreted in such a way because more unvaccinated are infected than vaccinated. If measured against the World Health Organization standard for vaccine approval, the mRNA vaccines as assessed in this study would fail the WHO 50% vaccine effectiveness test, as even boosted vaccine effectiveness equaled 26.4%.

The results of this AMED-funded observational study were published in PLOS, Global Public Health.

The authors of this study emphasize some strengths, such as the comprehensive data collection conducted across all PCR centers in collaboration with the Hiroshima prefectural office. Considered an “extensive and unique epidemiological survey,” it represents a material contribution, “with no comparable large-scale study conducted in other prefectures of Japan.”

Of course, many limitations with such a study exist (and are mentioned below), but the authors promote their use of detailed information representing occupation and various risk factors (likelihood of close contact and pre-existing conditions) that they articulate enhancing the study’s robustness. Such factors, adjusted within the model, account for potential confounding influence.

PCR Positivity Rates by Vaccination Status: the X axis represents the study period; y axis represents the test positivity rate. The figure displays PCR positive rates for three distinct groups: non-vaccinated, vaccinated with two doses and vaccinated with three doses (booster).


Reporting PCR test positivity rates were 7.9%, 4.5%, and 2.8% for the non-vaccinated (non-vaccinated, vaccinated with a single dose, and vaccinated with two doses less than 14 days ago), vaccinated with two doses (vaccinated over 14 days ago), and three doses, respectively.

Presenting both unadjusted and adjusted analyses, vaccine effectiveness of two doses against infection were 38.5% (95% confidence interval [CI]: 32.8%–43.8%) and 34.7% (95%CI: 28.4%–40.4%), respectively, compared to the non-vaccinated group. Vaccine effectiveness of three doses was 33.8% (95%CI: 25.0%–41.5%) and 26.4% (95%CI: 16.4%–35.2%), respectively, compared to those vaccinated with two doses.

While the authors cite these results in the positive (vaccine affords protection), not only should the actual vaccination effectiveness rate be questioned, but also noted that three dose rates is lower than the VE for two jabs. The authors emphasize the protective influence of the vaccine countermeasures.


All observational studies fall short in terms of evidentiary strength as compared to randomized controlled trials. Consequently, the team’s findings should be interpreted with caution and consideration of such inherent limitations, which include:

No specified estimation of VE for individual vaccine types, booster types (heterologous or homologous), time-sensitive effectiveness (effectiveness at different intervals post-vaccination), or the interval between vaccine doses.
The generalizability of our results may be affected due to the nature of this study population. For example, PCR test recipients who visited a PCR center may have a higher level of health consciousness compared to those who didn’t visit a PCR center.


Another finding of low vaccine effectiveness

How durable was the original monovalent mRNA vaccine when measured against prevention of COVID-19 Omicron-associated hospitalization involving children and adolescents? The Overcoming COVID-19 investigator network recently reported on this data between 2020 and 2023.

The results are challenging, evidencing rapidly waning vaccine effectiveness (VE) based on the known confluence of factors from mutating viral pathogens to the possibility of immunological imprinting (antigenic sin), and frankly, vaccines not engineered for breadth or durability results.

How severe is the waning VE? It is significant. For example, when measuring against hospitalization, VE should be substantially high, as the threshold is different for this class of product than preventing transmission. When the hospitalization incidence occurs a mere four months or more after the hospitalization event the VE rate equals 19% and ranges from as low as 2% to up to 32%. This is a remarkably weak rate evidencing serious concern about the longer-term viability of the COVID-19 countermeasures. The targeted threshold of effectiveness needs to be significantly higher for our children and adolescents.


Authoring this study paper was the Overcoming COVID-19 investigators, part of a study seeking to characterize the development of COVID-19 complications in children and young adults as a consequence of exposure to COVID-19 including the Multisystem Inflammatory Syndrome in Children (MSI-C).

MIS-C emerged as a significant concern during the SARS-CoV-2 delta surge but waned during Omicron.

A real-time surveillance and observational study, the investigation included prospective enrollment of study participants with collection of blood and respiratory samples. What were the risk factors and outcomes of COVID-19 critical illness in the pediatric population? What defined complications in this young vulnerable court and linked to SARS-CoV-2? What about predictive markers of these complications? Finally, what characterized the development and maintenance of adaptive immunity? The Overcoming COVID-19 investigators sought to answer these, and other questions.

How durable is pediatric vacation with use of mRNA COVID-19 vaccine countermeasures? This was a central question driving this investigation. Overall, parents have increasingly opted to keep their children away from the COVID-19 countermeasures.

The authors, represented by corresponding author Laura Zambrano, Ph.D., M.D., senior epidemiologist at the Centers for Disease Control and Prevention (CDC), report that during December 19, 2021–October 29, 2023, the Overcoming COVID-19 Network evaluated vaccine effectiveness (VE) of ≥2 original monovalent COVID-19 mRNA vaccine doses against COVID-19–related hospitalization and critical illness among U.S. children and adolescents aged 5–18 years, using a case-control design.

The authors report, “Too few children and adolescents received bivalent or updated monovalent vaccines to separately evaluate their effectiveness” which most certainly is a telling data point as to the reality of demand for COVID-19 vaccines among parents and their children and adolescents.

For this particular study, the authors led by Zambrano point out that a majority of individuals tested positive for SARS-CoV-2 fell in the unvaccinated category, “despite the high frequency of reported underlying conditions associated with severe COVID-19.”


So, what was the vaccine effectiveness of the original monovalent vaccine against COVID-19–related hospitalizations?

According to the findings here, VE equaled 52% (95% CI = 33%–66%) when the most recent dose was administered <120 days before hospitalization, and 19% (95% CI = 2%–32%) if the interval was 120–364 days. TrialSite suggests the rate of 19% VE in preventing hospitalization 4 months and on represents an incredibly weak record.

Another measure, or slice of the data, was a vaccine administered any time within the previous year, which looks at least somewhat better than the pathetic 19% figure, especially for this category of the original monovalent vaccine against COVID-19–related hospitalization was 31% (95% CI = 18%–43%).

When looking at the definition of hospitalization with more granularity, diffident VE rates emerge. For example, looking at the category “COVID-19-related illness” defined as receipt of noninvasive or invasive mechanical ventilation, vasoactive infusions, extracorporeal membrane oxygenation, and illness resulting in death and VE rates equaled the following:

VE Scenario

VE was similar after excluding children and adolescents with documented immunocompromising conditions.

The CDC authors emphasize that the receiver of ≥2 monovalent mRNA COVID-19 vaccines are associated with fewer COVID-19 hospitalizations during the Omicron period in children and adolescents aged 5–18 years. But this
“protection from original vaccines was not sustained over time, necessitating increased coverage with updated vaccines.”

A majority of hospitalized kids were unvaccinated, and few had received updated vaccine doses despite a high prevalence of underlying comorbidities associated with more severe disease.

The social determinants of health continue to be a factor in vaccination trends, with vaccination rate decline associated with social vulnerability.

The authors acknowledge carefully the overall dismal VE rates, stating:

“VE of original monovalent doses against COVID-19–related pediatric hospitalizations were lower than previous VE estimates reported by the Overcoming COVID-19 Network before Omicron emergence.”

The CDC does not include any risk-benefit analysis within its recommendations, e.g., avoids discussion of myocarditis/pericarditis risk to young adolescent males and avoids the topic of natural immunity when recommending that “all children and adolescents receive updated COVID-19 vaccines to protect against severe COVID-19.”


Not surprisingly, many limitations suggest any interpretation done so with caution. Dr. Zambrano and team identify four major limitations including:

SARS-CoV-2 infection-induced immunity was not assessed

Limited viral sequencing data prevented consideration of subvariant-attributed immune evasion

Limited coverage with bivalent vaccines and currently recommended updated monovalent vaccines precluded the estimation of VE of these formulations

Previously healthy children and adolescents accounted for <20% of case-patients, limiting generalizability




Thursday, April 18, 2024

Japanese Epidemiological Bombshell: Investigators Link Mass mRNA Vaccination and Adverse Cancer Outcomes

Physician-Epidemiologist Miki Gibo affiliated with Matsubara Clinic and National Health Insurance Yusuhara Hospital in Yusuhara, Kochi, Japan and colleagues recently had a disturbing paper published in Cureus. Peer reviewed, the team for Japanese researchers look into the question of excess deaths during and after COVID-19 and incidence of cancer mortality after the third MRNA COVID-19 vaccine.

While talk or “turbo cancer” is rampant on social media such as X any such claims require significant evidence. TrialSite has chronicled real world data and tracked the growing number of case series involving some form of cancer in association to COVID-19 vaccines. But case series-based studies are not designed to establish causation. In collaboration with React19, TrialSite supported that patient advocacy’s development of the Scientific Publications Directory. Now managed by React19, approximately 200+ studies involving cancer and COVID-19 vaccination are available in this online study hub.

Dr. Gibo and colleagues discuss in their Cureus piece excess deaths including cancer in Japan, a population that was heavily exposed to mRNA COVID-19 vaccines, and one that is rapidly aging. Their recent output was published just days ago in Cureus. Importantly, while the findings herein raise profoundly disturbing questions, this study output does not equate to confirmatory evidence that COVID-19 vaccines and cancer have some causal linkage. More investigation is necessary.

The Study

The team in this study evaluated how age-adjusted mortality rates (AMRs) for different types of cancer in Japan changed during the COVID-19 pandemic (2020-2022).

Tapping into official Japanese statistics and employing logistic regression analysis, the investigators compared observed annual and monthly AMRs with predicted rates based on pre-pandemic (2010-2019) figures.

What are the findings?

Interestingly, the team observed no significant excess mortality during the first year of the pandemic (2020). This data point resonates with other national data TrialSite reviewed in the United States, for example.

Disturbingly, Dr. Gibo and colleagues observed excess cancer mortality in 2021, after mass vaccination with the first and second vaccine doses. This data includes what the medical researchers report observations involving “significant excess mortalities” for all cancers, along with upward trends with select types of the disease.

This study discusses possible explanations for these increases in age-adjusted cancer mortality rates but is not designed to prove causation.


The Japanese medical researchers raise disturbing questions with this significant study. For example, as published in the peer-reviewed Cureus the team observed in 2022, after mass population exposure to COVID-19 mRNA vaccines “statistically significant increases in age-adjusted mortality rates of all cancer and some specific types of cancer, namely, ovarian cancer, leukemia, prostate, lip/oral/pharyngeal, pancreatic, and breast cancers.”

Declaring that the data exhibit “particularly marked increases in mortality rates of these ERα-sensitive cancers,” Dr. Gibo and colleagues suspect that the findings “may be attributable to several mechanisms of the mRNA-LNP vaccination rather than COVID-19 infection itself or reduced cancer care due to the lockdown,” the latter of which could just as well be an explanation.

But the former could be an explanation as well, and that’s a real problematic proposition needing immediate investigation. Gibo and colleagues certainly recommend more research.


Not clinically validated, the team taps into official data sources employing descriptive statistics. The authors suggest more statistical investigation associated with vaccination status is necessary to bolster any evidence.

The Study Authors’ Questions

Why are AMRs of ovarian cancer, leukemia, prostate, lip/oral/pharyngeal, pancreatic, and breast cancers increased significantly beyond the predicted rates, especially in 2022, in Japan?

Does the research of Solis et al. on the binding ability of S-protein of SARS-CoV-2 against over 9,000 human proteins matter here? In that research, the authors point out that S-protein specifically binds to ERα and upregulates the transcriptional activity of Erα. Importantly, all of the identified cancers are known as estrogen and estrogen receptor alpha (ERα)-sensitive cancers.

The present study points out more estradiol (E2) to human breast cancer cells can lead to proliferation of the cancer cells, whereas the addition of raloxifene, a selective ERα modulator, inhibits proliferation.

Could ERα-mediated transcription induce endogenous DNA double-strand breaks (DSBs) in ER-sensitive cancers? According to some research, “Transcriptionally activated ERα induces DSBs by topoisomerase II and the recently known R-loop/G-quadruplex structures formation, significantly increasing the need for BRCA1 for their repair in breast cancer cells.”

Dr. Gibo and colleagues point out that in their study they present “nuclear translocation of mRNA and S protein with the nuclear localization signal [90], and an in silico bioinformatic analysis showed interactions between the S2 subunit of S-protein and BRCA1, BRCA2, and P53 [91], possibly resulting in their sequestration and dysfunction.”

Could it be the case that a possible co-occurrence of high BRCA1 demand to repair DNA damage triggered by activated transcription via ERα bound with S-protein along with dysfunction of BRCA1 sequestrated by S-protein raises concerns about increased cancer risk in ERα-sensitive cells in mRNA-LNP SARS-CoV-2 vaccine recipients?


Reportedly, During Covid, The Elderly Were the First to be Sacrificed

Last month, it was reported former New York State governor Andrew Cuomo had been subpoenaed by Congress over elderly Covid deaths under Cuomo’s administration. The ex-governor was accused of using under-reported numbers to bolster his handling of COVID-19 especially with the number of deaths which occurred in 2020, when Cuomo required nursing homes to accept elderly Covid positive patients. As a result of this policy, Cuomo has been accused of causing the death of over 15,000 New Yorkers. His deposition in front of the Republican led House Select Subcommittee on the Coronavirus Pandemic is scheduled for May.

“After misleading the public and filtering the truth from the American people regarding how many COVID-19 deaths occurred in nursing homes, Andrew Cuomo has been dodging our committee, delaying our investigation and refusing to take accountability,” New York Rep. Nicole Malliotakis (R-Staten Island), one of the panel’s members, said in a statement. Malliotakis added, “His misguided policies led to the deaths of more than 15,000 New Yorkers. His testimony is crucial to helping us prevent a tragedy like this from occurring ever again.” But the bigger question is, was this the only occurrence of Covid neglect? Apparently not.

United Kingdom

In 2023, TrialSite reported on a lawsuit against the British Government by the families of elderly patients who died in nursing homes. The families claimed not enough was done to take care of their loved ones and infected patients were transferred into nursing homes and spread the virus. This is eerily similar to the events which will soon have former New York State governor Andrew Cuomo appearing in front of a Congressional committee. It seems, however, there are more instances of Covid elder abuse in the UK.


In a recent article in the Daily Mail, there is a report of Do Not Resuscitate (DNR) papers being forged. Relatives of elderly patients say their loved ones were left to die against the wishes of the families. This is now being investigated by the Scottish Covid-19 inquiry which has named the use of DNRs as one of the primary reasons for its investigation. According to one relative of an elderly woman who died, the relative’s name and signature were on a DNR authorization but the relative never saw nor signed the document.

The Scottish government insisted there was no change in advice given to clinicians during the pandemic regarding the use of DNRs, but the evidence in this area has shown, so far, this not to be true. Administrators at some elder care homes in Scotland have been accused of having a culture where health professionals urged nursing homes to update their “anticipatory care plans” for residents. One administrator says she was told, “You need to look at who doesn't have DNRs because they will now need to have one.” Allegedly, after this conversation DNRs were in place for all residents of the nursing home and the administrator wondered to what extent family members had been consulted. The impression the administrator had was if an elderly resident became ill with Covid, they wouldn’t go to the hospital. The administrator added, “You could clearly see that, if they went to hospital, they had a really good chance of improving, of getting over what was making them unwell in the first place. But it was almost like, you were not playing God, but it was just 'no, you can't go, so you just have to stay.” According to the administrator it was difficult for the nursing home to access ambulances, paramedics or hospital beds.

It is alleged the Scottish government allowed this practice. In January, TrialSite reported Scottish police were looking into the possibility of an “industrial sized’ cover up by Scottish ministers regarding deaths of elderly patients in nursing homes due to Covid. Twenty-two official internal complaints were raised concerning the Scottish government’s official response to the nursing home deaths. Again, on this issue, DNRs were involved.

Covid Devastated Nursing Homes
The pandemic neglect in nursing homes wasn’t limited to the UK. According to an article by the Kaiser Family Foundation in 2022, Covid deaths in elder care facilities accounted for at least 23% of all Covid deaths in the United States as of January 2022. Canada was ranked last for the amount of deaths caused by Covid in nursing home facilities.

The Centers for Medicare & Medicaid Services (CMS) (2021) reported 570,626 nursing home residents' infections and 112,383 residents’ deaths in the USA before the wide availability of COVID-19 vaccination in 2020 for nursing home residents (e.g., Pfizer, Moderna, and Johnson and Johnson). Since the mass vaccination program another 57,808 residents have died, at least a percentage of them, fully vaccinated against COVID-19.

TrialSite chronicled disproportionate morbidity and mortality among the nation’s most vulnerable, sick and elderly residents.

According to the Centers for Medicare data 170,191 elderly died in long term care during the pandemic. In what seems a low rate, only 43.3% of long-term care residents are up to date with their COVID-19 vaccines. Why would this be the case?

What is truly unfortunate is it seems the elderly have become political pawns and tragically, easily dispensable. It is problematic when a politician actually admits he covered up elderly deaths because the political data would be used against him. The shame of all of this remains the reality that this represents a worldwide problem (at least in developed nations in English speaking countries) and a sad comment on health care, politics and the world when the elderly—that is our parents and grandparents-- are so easily tossed away.




Wednesday, April 17, 2024

Rand Paul Pulls Back Curtain on the ‘Great COVID Cover-up’

In an explosive new op-ed, Sen. Rand Paul (R-Ky.) claimed that at least 15 separate federal agencies knew that attempts to create a COVID-19-like coronavirus were being undertaken at the Wuhan Institute of Virology as early as January 2018.
Yet heads of these agencies did not reveal this information to the public; for years, they actively refused to release information on the project to lawmakers such as Dr. Paul, who were attempting to provide congressional oversight.

“For years, I have been fighting to obtain records from dozens of federal agencies relating to the origins of COVID-19 and the DEFUSE project,” Dr. Paul, who in March revealed he was formally launching a bipartisan investigation into the virus’s origins with Democratic Sen. Gary Peters of Michigan, wrote.
The DEFUSE project refers to a proposal submitted by EcoHealth Alliance, a U.S.-based nongovernmental organization headed by British zoologist Peter Daszak, and the Wuhan Institute of Virology. The purpose of the proposal was to “insert a furin cleavage site into a coronavirus to create a novel chimeric virus.”

Dr. Paul also identified two additional parties that were part of the original plan to create chimeric coronaviruses at the Wuhan lab: the National Institute of Allergy and Infectious Diseases, the federal agency formerly headed up by Dr. Anthony Fauci, and Dr. Ian Lipkin, a professor of epidemiology and one of the authors of the now-disgraced “Proximal Origin” paper. The authors of the paper, which was published in Nature in March 2020, stated that evidence clearly indicated that SARS-CoV-2 emerged naturally, even though privately, the authors expressed clear concerns that evidence suggested the virus was genetically designed.

Some scientists have already raised ethical concerns in response to the revelation.

“We now know Ian Lipkin was part of the initial DEFUSE proposal,” Bryce Nickels, a professor of genetics at Rutgers University, said in response to the revelation. “Everything he has said about COVID origins and his role in the fraudulent ‘Proximal Origins’ paper must now be reconsidered in the wake of these new revelations.”

It’s not just Lipkin, of course.

All of these parties failed to speak up when COVID-19, one of the deadliest viruses in a century, emerged from Wuhan, Dr. Paul said, and details of the DEFUSE project may not have come to light at all if not for a whistleblower (identified as Lt. Col. Joseph Murphy).

More details of what the Kentucky senator calls “the Great COVID Cover-up” are likely to materialize as Dr. Paul and Mr. Peters continue their investigation. But an abundance of evidence already shows it’s no exaggeration to use that word: coverup.

Dr. Paul is hardly the first government official to use the term.

Nearly a year ago, David Asher, a bioweapons specialist who led the State Department’s investigation into the origins of COVID-19, sat down with New York magazine journalist David Zweig and explained why there has been so little progress made in discovering the origins of COVID: Those with institutional power don’t want answers.

“It’s a massive coverup spanning from China to DC,” Mr. Asher said. “Our own state department told us, ‘Don’t get near this thing; it’ll blow up in your face.’”

Other government whistleblowers have also attempted to expose the coverup.

In August, the CIA confirmed that the agency was “looking into” allegations from a CIA whistleblower who claimed that analysts tasked with determining the origins of COVID were offered “significant” financial incentives to change their assessment that COVID likely emerged accidentally from the Wuhan lab. (It’s worth noting that Dr. Fauci allegedly was admitted to agency headquarters “without a record of entry” while the CIA was conducting its investigation into COVID’s origins.)

The reason the government would cover up DEFUSE becomes obvious when one analyzes the nature of the proposal, which British author Matt Ridley weeks ago noted included a great many “wacky” (and reckless) ideas such as spraying vaccines into bat caves to immunize them.

“In the end, what they were doing was making more dangerous viruses, with a view of understanding them,” Mr. Ridley said. “It looks very strongly as if in trying to prevent a pandemic they may have caused one.”

While we still do not know this for certain, it looks increasingly likely that COVID-19 was born of gain-of-function research that was partially funded by the U.S. government.
Though this result would be shocking to many, especially those who see the state as virtuous and infallible, it’s far less surprising to students of history and economics.

“The worst evils which mankind ever had to endure were inflicted by bad governments,” Ludwig von Mises wrote in “Omnipotent Government.” “The state can be and has often been in the course of history the main source of mischief and disaster.”

The reason for this is obvious. The more power is concentrated, the less accountable it becomes, and power without accountability is a recipe for disaster.


Australia: Senator Claims TGA ‘Overriding’ Experts While Processing Vaccine Injury Claims

Senator Gerard Rennick has alleged—under parliamentary privilege in the Senate—that the Therapeutic Goods Administration is “overriding the decision of the specialists” in refusing claims for vaccine injury from people who received COVID-19 vaccinations.

Services Australia administers the scheme, which offers people a way to seek a one-off compensation payment, instead of going through legal proceedings, if they experienced harm from a vaccine.

The Scheme was designed to “compensate for losses due to the harm ... suffered” and not for “pain and suffering.” The compensation covers lost earnings, out-of-pocket expenses, paid attendant care services, and “deceased ... vaccine recipient payments and funeral costs.”

To meet the criteria for the payment, Services Australia’s website says a person must have:

received an approved COVID-19 vaccine.

met the definition of harm, for example, an administration-related injury or one of the clinical conditions listed in the policy.

been admitted to hospital as an inpatient, or seen in an outpatient setting for an eligible clinical condition.

been admitted to hospital as an inpatient for an administration-related injury.

experienced losses or expenses of $1,000 or more.

The site also lists the eligible conditions including myocarditis (inflammation of the heart muscle) and the autoimmune disorder Guillain Barre Syndrome.

A claimant must have their condition verified by “a medical specialist in the relevant field of practice” (for instance, a cardiologist for myocarditis), and then send the medical report and evidence of the expenses being claimed for assessment by Services Australia.

Senator Claims to Have ‘Insider’ Informant

Mr. Rennick told the Senate that he had spoken to “an insider from the TGA” who had since resigned, and who “played a big role in designing this scheme.”

“The whole point of that scheme was that once the injured person got a specialist to say that the person was injured by the vaccine, he or she would be entitled to compensation. Now that is not happening,” the senator said.

“What is happening is Services Australia make these people wait [on average] 297 days to get a decision. Many of them can no longer work. They are seriously ill. They have to do all the legwork of trying ... see a specialist, a cardiologist or a rheumatologist, and that takes a lot of work. It’s very expensive. You’ve got to go and get MRIs or something to back [it] up. And then they’ve basically been neglected.”

He alleged that, once the claim came up for a decision, “what they do is [refer it] back to the TGA, [and the] TGA is a turning around and saying ‘we are overriding the decision of the specialists who actually examined the patient.’”

“Now my insider tells me these doctors at the TGA are not qualified to be overriding specialists. And I believe that if you haven’t examined the patient who you decide this isn’t actually a vaccine injury, how would you know?”

Mr. Rennick said he had talked to scientists—whom he did not name—who told him that “you will never know while a person’s leaving because you can’t take tissue samples from living people. So we are operating in the dark here in regards to our ability to examine what’s really going on as a result of these vaccine injuries.”

Only 14 Deaths Recognised as Vaccine-Related

Senator Rennick claimed there were 1,000 reports of suspected deaths due to the vaccines in the country.
“And how many have the TGA recognised? 14,” he said.

“When you press the TGA and you say to them, ‘Can you actually prove this wasn’t a vaccine?’ They say, ‘No, we can’t.’

He also claimed there were 10,000 unexplained excess deaths during the period between May and December 2021 when the vaccines were being administered.




Tuesday, April 16, 2024

Esteemed Australian Immunologist/Virologist on Long COVID & Long Vax: Spike Protein Pathogenicity

An author with the Australian Journal of General Practice, Emeritus Professor in Immunology, University of Queensland, Faculty of Science, now retired and independent to speak his mind, Robert Tindle, Ph.D. is no lightweight. Heavily published deep into the science of virology and immunology, he presently educates his peers about the plight of long COVID and long Vax patients.

Elaborating on the scope and severity of the crisis while directing attention to the patient's plight, Prof Tindle explains to the Australian medical establishment the mechanism of action now evidenced by mounting scientific literature concerning both long COVID and the vaccine injured, or long-Vax, the latter being not yet accepted, at least overtly, by medical establishments of the West. To alleviate patient suffering, a growing economic toll and a debilitated medical establishment, we must open our eyes to science, embrace the truth, and forge a new path forward.

Anywhere from 2% to 20% of individuals who are infected with SARS-Cov-2, the virus behind COVID-19, end up with post-acute sequelae of COVID-19 (PASC or long COVID), according to the World Health Organization (WHO), European Union and the UK and US governments. This condition occurs >12 weeks after the initial COVID-19 infection and can endure for many months, even years. Recently the University of Queensland Australia Emeritus Professor elaborates on the condition millions of people struggle with worldwide, with hundreds of thousands of people in Australia coping with either long COVID or long Vax.

The recent paper was published as a viewpoint in the Australian Journal of General Practice, emphasizing that the plight of long COVID patients cannot be underestimated. Prof Tindle reports the presence of long COVID digital support groups emerging as a civil society safety net, but the lack of institutional scientific and medical support leads to a mounting crisis for patients. They are not listened to, and health systems are not prepared for delivering the right care, meaning long COVID patients resort to self-prescribed medication with use of over-the-counter remedies for example, diet changes and the like.

A heterogeneous disease with myriad of symptoms (cardiac, pulmonary, hematological and neurological), the retired Australian scientist points to overlap with myalgia encephalomyelitis/chronic fatigue syndrome, postural orthopedic tachycardia syndrome (POTS) and other post-viral manifestations.

What’s behind lingering COVID-19 symptoms despite the clearing of the infection? No one can be certain and according to the Australian scientist, “Public officials are flying blind when it comes to long COVID and vaccination.” But Tindle introduces some of the unfolding science for explanations.

While patients are not able to find a trustworthy diagnosis, they are often required to seek multiple medical positions, and these patients are often told they are merely struggling with anxiety or post-pandemic mental health issues.

What’s the medium duration of long COVID symptoms? According to Tindle, it is five months, however, 10% of long COVID patients may experience symptoms at month 12. In fact, fatigue, shortness of breath and difficulty concentrating can persist with this patient cohort still by year two after infection.

Still what is up in the air is whether some people may never recover.

What are some biomarkers involved?

Patients struggling with long COVID may present elevated inflammatory biomarkers, such as interleukin-6, C-reactive protein, tumor necrosis factor-α), possibly functioning as a core set of blood biomarkers that can be used to diagnose and manage long COVID patients in clinical practice.

Economic Contagion

Prof Tingle reports that 20% of long COVID patients in the UK either stopped working or were not able to return to work six months after their initial infection. In Australia, 240,000 persons with long COVID can no longer work full time. Meanwhile, absenteeism on the job only grew, accelerated with long COVID.

Make no mistake, economies are impacted. From reduced working time to loss of earning capability, and the lack of diagnosis in countries like Australia, this means that many won’t be eligible for disability schemes.

With no guidelines for how long COVID patients can access social security and employment protection, the working classes are particularly vulnerable.

Nowhere to Turn?

Efforts at establishing long COVID clinics have not translated into sustained access to care. Without substantive treatment guidelines or support they become “little more than incident report centers.” Moreover, waiting times in such long COVID clinics can equate to many months. In fact, in places like Australia, Prof. Tindle informs us that many GPs are not even aware of such clinics!

However, some progress has been made in Europe, reports Tindle. Some European nations and the UK offer more established long COVID clinics offering everything from online recovery platforms to GP training and even specialty access for children.

Bombshell: COVID-19 Vaccination & Long COVID

While TrialSite has reviewed some study results suggesting that vaccination may have put a dent in long COVD, other credible studies imply no such connection. Frankly, the evidence is both mixed, and not strong enough for any claims that the COVID-19 vaccines inhibit long COVID.

But Prof. Tindle goes on the record, expressing his concern that “COVID-19 vaccination per se might contribute to long COVID, giving rise to the colloquial term ‘Long Vax.”

Importantly, while most national medical establishments in the West such as the United States or the UK don’t yet accept the premise that the spike protein manifested from mRNA vaccines can lead to damage, Tindle in this established Australian General Practitioners journal expresses his viewpoint that “the spike protein of SARS-CoV-2 exhibits pathogenic characteristics and is a possible cause of post-acute sequelae after SARS-CoV-2 infection or COVID-19 vaccination.”

Supporting the mRNA vaccine-induced spike protein as a pathogenic agent hypothesis, Tindle continues, “COVID-19 vaccines utilize a modified, stabilized prefusion spike protein that might share similar toxic effects with its viral counterpart.”

The Australian virologist/immunologist proffers, “A possible association between COVID-19 vaccination and the incidence of POTS have been demonstrated of 284,592 COVID-19 vaccinated individuals, though at a rate that was one-fifth of the incidence of POTS after SARS-CoV-2 infection.” He points to Kwan et al.

Hammering on a topic deemed taboo for at least a while in medical establishments, the vaccine induced spike protein pathogenicity represents a real problem, pointing to very real-world, well-established links to myocarditis risk.

And what about the problem of mRNA biodistribution? Throughout the pandemic, medical establishment actors and representatives informed that the COVID-19 vaccination was safe and effective, and that there were no risks of the mRNA-induced spike protein circulating in the body for longer periods of time, and in the process, ending up in far flung tissues and organs. The mRNA would simply flush out via the lymphatic system in a matter of days, maybe a week at the most.

Of course, TrialSite has chronicled the incidence and studies disproving this continuous myth, at least in a percentage of individuals receiving COVID-19 mRNA vaccines. Prof Tindle verifies this reality, reporting, “mRNA vaccines can result in spike protein expression in muscle tissue, the lymphatic system, cardiomyocytes and other cells after entry into the circulation,” citing Trougakos et al.

Moreover, growing evidence suggests, and Tindle confirms in his viewpoint that individuals receiving at least two doses of mRNA vaccine “display a class switch to IgG4 antibodies.” Citing Uversky et al., Tindle articulates an important point as “abnormally high levels of IgG4 might cause autoimmune disease, promote cancer growth, autoimmune myocarditis and other IgG4-related diseases (IgG4-RD) in susceptible individuals.”

Long Vax, Another Crisis

Tindle steps into the controversial topic of COVID-19 vaccine injured, or long vax, seamlessly and with ease and backed by the unfolding science, comparing it to long COVID in many ways.

Reaffirming a growing body of evidence observing COVID-19 vaccination, including boost courses, with “incidence of long COVID-like symptoms, adding further to public health officials’ concerns.”

And key to any resolution, including therapeutic options, would be to scientifically comprehend the cellular and pathological effects of COVID-19 vaccination with and without infection. Yet vaccine approvals, accelerated during the pandemic crisis, lacked any long term-safety data, a growing concern according to Prof Tindle given the possibility of immune dysfunction.

A key point Tindle seeks to make here is that it’s quite likely at least among susceptible individuals COVID-19 vaccinations could be associated with long COVID. Put another way, “It is perhaps, premature to assume that the past SARS-CoV-2 infection is the sole common factor in long COVID.”

Where to Go from Here?

From expressing hope that $50 million in Australia’s Medical Research Future Fund may help advance practical medical and scientific knowledge into the matter, Tindle also seems somewhat hopeful about a national center for disease control providing a national interrogative repository for what have been to date, “fragmented incidence and outcome data for long COVID.”

Tindle also points to a promising study last year led by scientists at QIMR Berghofer Medical Research Institute in Brisbane, Australia demonstrating in a preclinical study involving a model of peptide inhibitor of nuclear angiotensin-converting enzyme 2. The scientists reported in the prestigious peer-reviewed journal Nature Communications that this led to reversing “persistent inflammation driving long COVID” while also “reducing the latent viral reservoir in monocytes/macrophages” while associated with “reduced SARS-CoV-2 spike protein expression in monocytes from individuals who are recovered from infection.” Clinical trials were pending at the time last year, and TrialSite will do a follow up article on that discovery.

The message from this important viewpoint published in GP’s journal in Australia--more clearly needs to be done to help struggling patients, whether they are diagnosed with long COVID or long Vax.




Monday, April 15, 2024

Censored again

Google have just deleted my post of 24 March about myocarditis in children. It is however still available at its original source:

COVID Infection Not the Only Cause for Long COVID: Immunologist

Long COVID may not be solely caused by a COVID-19 infection given the lack of long-term safety data associated with the COVID-19 vaccine, an immunology professor has said.

In an externally peer-reviewed op-ed published by the Australian Journal of General Practice, Emeritus Professor Robert Tindle said that public health officials are “flying blind” when it comes to linking long COVID to post-COVID-19 vaccination.

“There is no consensus on what causes lingering COVID-19 symptoms long after the acute infection has cleared,” Mr. Tindle opined, adding that patients who are unable to secure a diagnosis for long COVID have sought multiple medical opinions only to be told the condition is due to “anxiety or post-pandemic mental issues.”

Long COVID is described by the World Health Organisation as the continuation or development of new symptoms three months after the initial SARS-CoV-2 infection, with these symptoms lasting for at least two months without any alternative explanation. This definition is now accepted by the Australian government.

The median time for long COVID symptoms is five months, with 10 percent of patients having symptoms at 12 months, according to a study.

Fatigue, shortness of breath, and difficulty concentrating have been reported in patients up to two years post-infection.

Mr. Tindle said that the spike protein of SARS-CoV-2 exhibits pathogenic characteristics, and is a possible cause of acute symptoms after a COVID-19 infection or post-vaccine.

“COVID-19 vaccines utilise a modified, stabilised prefusion spike protein that might share similar toxic effects with its viral counterpart,” Mr. Tindle said.

“A possible association between COVID-19 vaccination and the incidence of POTS (postural orthopaedic tachycardia syndrome) has been demonstrated in a cohort of 284,592 COVID-19-vaccinated individuals, though at a rate that was one-fifth of the incidence of POTS after SARS-CoV-2 infection.”

Mr. Tindle listed other associations with long COVID following the uptake of the COVID-19 vaccine, including an increase in myocarditis post-vaccination, elevated spike proteins in muscle tissues, the lymphatic system, and the circulatory system, and elevated levels of IgG4 antibodies that are linked to the promotion of cancer.

“There are clear implications for vaccine boosting where these and similar observations relating to COVID-19 vaccination and the incidence of long COVID-like symptoms are substantiated, adding further to public health officials’ concerns,” he said.

“Understanding the persistence of viral mRNA and viral protein and their cellular pathological effects after vaccination with and without infection is clearly required.

“Because COVID-19 vaccines were approved without long-term safety data and might cause immune dysfunction, it is perhaps premature to assume that past SARS-CoV-2 infection is the sole common factor in long COVID.”

Moreover, Dr. Aseem Malhotra—Britain’s high-profile cardiologist and previous supporter of mRNA COVID vaccines—previously told The Epoch Times that heart complications—such as cardiac arrhythmia, heart failure, cardiac arrest, myocarditis, and pericarditis—have seen an uptick since the vaccine rollout.

“Long vax” is the colloquial term used to describe long COVID caused by vaccination.

Long COVID From Omicron Variant

Meanwhile, a study by the Australian National University (ANU) has found the risk of developing long COVID from the Omicron variant is higher than originally thought.

The Australian study found that in a highly vaccinated population not broadly exposed to earlier SARS-CoV-2 variants, 18 percent of people infected with the Omicron variant reported symptoms consistent with long COVID 90 days after infection.

“Despite reports that the risk of long COVID may be lower following Omicron infections than with earlier SARS-CoV-2 variants, we found that the burden of long COVID may be substantial 90 days after Omicron infections,” lead researcher Mulu Woldegiorgis said.

Additionally, the study found that 90 percent of the study participants with long COVID reported experiencing multiple symptoms, such as tiredness and fatigue (70 percent), followed by difficulty thinking or concentrating (brain fog), sleep problems, and coughing. A third of women in the study reported changes in their menstrual cycle.

However, a study by Germany’s Martin Luther University Halle-Wittenberg has shown that unvaccinated people infected with the Omicron variant had the lowest risk of long COVID.
The study found that while previous infections reduce the risk of long COVID by 86 percent, vaccination status prior to COVID infection is irrelevant to a person’s risk of developing long COVID.

However, the authors of the German study acknowledged that none of the participants were given an actual diagnosis of long COVID or tested for comorbidities.

Long COVID Presents Health and Financial Challenges

Mr. Tindle outlined the health and financial challenges faced by Australians who have long COVID, saying that support measures need to be in place for those who suffer from the chronic condition.

According to a 2022 study (pdf) by the Australian National University (ANU), approximately 500,000 adult Australians, or 4.7 percent have experienced long COVID.

Mr. Tindle described the frustrations expressed by long COVID support groups, such as the Australian Long COVID Community Facebook Support Group, including inadequate health system responses in dealing with long COVID.

“The outcome for some of those experiencing long COVID is self-prescribed medication using over-the-counter remedies and dietary changes based on potentially conflicting or misleading online information. Some speak of a substantial proportion of their income being used this way,” he said.

However, Mr. Tindle did acknowledge the listings of antiviral drugs for COVID such as Paxlovid (nirmatrelvir and ritonavir) and Lagevrio (molnupiravir).

An estimated 240,000 of those with long COVID no longer work full time, thus affecting the economy, Mr. Tindle said.

“Reduced to working part-time to cope with unwellness, those with long COVID commonly report having to wait a year or more before receiving a diagnosis,” he said.

“Without a definitive diagnosis, those with long COVID are not eligible for Job Seeker, the Disability Support Pension and National Disability Insurance Scheme (NDIS) protection under the Fair Work Act, thereby conferring long-term financial difficulties for themselves and their dependents.

“There is a need for guidelines on how those with long COVID can access social security and employment protection.”

Mr. Tindle added that both the federal and state health departments need to provide more guidance to primary healthcare providers on handling long COVID.

“Although some states have established long COVID clinics, some of these at least are of little help to the patient in providing substantive treatment guidelines or support and are little more than incident report centres,” he said, adding that the wait time for a long COVID clinic is usually months, with some GPs unaware of the clinics’ existence.

“Long COVID is not an easy medical condition for clinicians, health administrators, support systems, or patients. The Australian health system is already stretched in coping with other chronic medical conditions,” he said.

“Nevertheless, we must do better than in the approximate three years since long COVID was first reported.”